InfertilityPhase 4NCT01682642
The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis.
A Phase 4 study testing Zoladex in people with Infertility and Endometriosis, run by AZ Jan Palfijn Gent at 1 site in Belgium.
Trial summary
In this study of endometriosis patients we compare a common treatment of surgical therapy and medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy. In both cases they immediately start In Vitro Fertilization (IVF) treatment. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility, Endometriosis
- What is being tested?
- Zoladex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2012to Oct 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- laparoscopical vaporization of endometriosis
- 1,2, 3e IVF cycle
- endometriosis stage I and II
- younger than 38 years
Who cannot join
- endometriosis cysts
- uterine pathology
- endocrinological diseases and problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IVF Outcome in Patients With Peritoneal Endometriosis. The Impact of a Hormonal Treatment of the Endometriosis Prior to the IVF on the Pregnancy Rates.
In this study of endometriosis patients we compare a common treatment of surgical therapy and medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy. In both cases they immediately start In Vitro Fertilization (IVF) treatment.
- Conditions
- Infertility, Endometriosis
- Being tested
- Zoladex
- Keywords
- endometriosis, pregnancy, In Vitro Fertilization (IVF)/Intra Cytoplastic Sperm Injection (ICSI), peritoneal implants, embryo quality
- Medical subject headings
- Infertility, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZoladexDrug
after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment
| Study group | Role | What they receive |
|---|---|---|
| Zoladex | Active comparator | After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. Receives: Drug: Zoladex |
| vaporization only | No intervention | Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Metaphase II Cells (MII)
number of MII cells retrieved
Measured: 3 weeks
Secondary outcomes (5)
Pregnancy Rate
The number of ongoing pregnancies obtained which still is the most important issue for the patients.
Measured: 12 weeks
Good Embryo Quality
The development of the embryo at the time of transfer on day 3. Good quality is defined by more than 7 cells and less then 20% fragmentation on day 3.
Measured: 3 days after oocyte retrieval
Number of Pro Nuclear Cell (2PN)
number of 2PN
Measured: 1 day after oocyte retrieval
Number of Cryopreserved Embryos
number of blastocytes that can be cryopreserved
Measured: 1 week after oocyte retrieval
Total Follicle Stimulating Hormone (FSH) Dose
total dose of FSH needed at the end of stimulation
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Jan Palfijn Gent
- Sponsor type
- University, hospital or other
- Collaborators
- Onze Lieve Vrouw Hospital
- Responsible party
- Principal investigator, Dr. Decleer Wim, AZ Jan Palfijn Gent
- Investigators
- Wim Decleer, gynecologist, Principal investigator, Fertility Center AZ Jan Palfijn GentPaul Devroey, Professor, Study chair, Fertility Center AZ Jan Palfijn Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682642
- Sponsor's protocol ID
- 2012-000784-25
- Status last verified
- Mar 2015
- First submitted
- 23 Aug 2012
- Last updated
- 20 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVF Outcome in Patients With Peritoneal Endometriosis. The Impact of a Hormonal Treatment of the Endometriosis Prior to the IVF on the Pregnancy Rates.
- ClinicalTrials.gov ID
- NCT01682642
- Acronym / sponsor ID
- 2012-000784-25
- Conditions
- Infertility, Endometriosis
- Keywords
- endometriosis, pregnancy, In Vitro Fertilization (IVF)/Intra Cytoplastic Sperm Injection (ICSI), peritoneal implants, embryo quality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AZ Jan Palfijn GentUniversity, hospital or other
- Collaborators
- Onze Lieve Vrouw Hospital
- Study start
- Mar 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Posted 20 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study of endometriosis patients we compare a common treatment of surgical therapy and medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy. In both cases they immediately start In Vitro Fertilization (IVF) treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zoladex | Active comparator | Drug: ZoladexAfter surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. |
| vaporization only | No intervention | –Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- laparoscopical vaporization of endometriosis
- 1,2, 3e IVF cycle
- endometriosis stage I and II
- younger than 38 years
Key exclusion criteria (3 listed)
- endometriosis cysts
- uterine pathology
- endocrinological diseases and problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoladexafter surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment | Drug | Zoladex |
Primary outcome
Number of Metaphase II Cells (MII)
Time frame: 3 weeks
number of MII cells retrieved
5 secondary outcomes
Pregnancy Rate
Time frame: 12 weeks
Good Embryo Quality
Time frame: 3 days after oocyte retrieval
Number of Pro Nuclear Cell (2PN)
Time frame: 1 day after oocyte retrieval
Number of Cryopreserved Embryos
Time frame: 1 week after oocyte retrieval
Total Follicle Stimulating Hormone (FSH) Dose
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wim Decleer, gynecologist principal investigator
Fertility Center AZ Jan Palfijn Gent
Paul Devroey, Professor study chair
Fertility Center AZ Jan Palfijn Gent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoladex in people with Infertility and Endometriosis, run by AZ Jan Palfijn Gent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Metaphase II Cells (MII) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.